Other safety alerts
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| Australia: Dienogest and risk of venous thromboembolism: Update |
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Therapeutic Goods Administration (TGA) announces that the Product information (PI) documents for combined oral contraceptives containing dienogest have been updated to include more detailed information on the risk of venous thromboembolism.
A review by the TGA in 2016 found that while the risk of venous thromboembolism (VTE), such as deep vein thrombosis and pulmonary embolism, is generally rare and occurs in approximately 2 in 10,000 women, the risk is slightly increased in women using a combined oral contraceptive (COC) containing ethinylestradiol and a progestogen. However, the degree of risk varies depending on the progestogen. At the time of the 2016 review, the risk of developing VTE from a combined oral contraceptive containing dienogest was listed as 'not yet known'.
Since 2016, the sponsor for both Valette (dienogest/ethinylestradiol) and Qlaira (dienogest/estradiol valerate) conducted a meta-analysis of four prospective cohort studies investigating the VTE risk associated with short- and long-term use of contraceptives containing dienogest/ethinylestradiol and levonorgestrel/ethinylestradiol. The sponsor also reviewed epidemiological studies which described variable risk estimates for VTE with dienogest/ethinylestradiol and levonorgestrel/ethinylestradiol. The risk of VTE in women taking dienogest/ethinylestradiol was estimated to be 8–11/10,000 in a year compared to 5–7/10,000 for women taking levonorgestrel/ethinylestradiol.
As a result of these analyses on VTE, the sponsor has included additional detail in the PI for dienogest/ethinylestradiol (Valette):
- Epidemiological studies, that compared the risk of VTE associated with use of dienogest/ethinylestradiol to the risk with use of COCs containing levonorgestrel/ethinylestradiol reported differing results ranging from no difference in risk to a three-fold increase in risk.
- Meta-analysis of four large prospective cohort studies yielded an adjusted Hazard Ratio of 1.57 (95% Confidence Interval, 1.07-2.30) for VTE risk with Valette compared to COCs containing levonorgestrel/30µg ethinylestradiol. These studies cover 38,708 women –years of exposure to Valette.
Similar warnings about the risk of VTE have also been added to product information in Europe based on a recommendation from the European Medicines Agency.
A specific and robust study to address the risk of VTE with the use of estradiol valerate (Qlaira) has been conducted. The INAS-SCORE study showed that Qlaira was associated with a similar or even lower risk of VTE compared to levonorgestrel-containing COCs or other COCs.
In women who have been using a dienogest-containing contraceptive without a problem, there is no reason to stop taking it based on this updated information. However, it is important that women are aware of the risk of VTE and its signs and symptoms such as pain or swelling in the legs, sudden unexplained breathlessness, rapid breathing or cough, and chest pain.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/publication-issue/update-dienogest-and-risk-venous-thromboembolism
In Hong Kong, there is only one registered pharmaceutical product which is a combined oral contraceptive containing dienogest, namely, Qlaira (dienogest/estradiol valerate) Tab (HK-59784). The product is registered by Bayer Healthcare Limited, and is a prescription-only medicine. So far, the Department of Health (DH) has received 2 cases of adverse drug reaction related to Qlaira, of which one case is related to venous thromboembolism. The local product insert of Qlaira includes safety information on the risk of blood clots in the veins with combined oral contraceptives. The DH will remain vigilant on safety update of the product issued by other overseas drug regulatory authorities.
Ends/Wednesday, Jun 23, 2021
Issued at HKT 16:00
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